The vaccine, mRNA-4157/V940, is designed to stimulate an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour, while Keytruda increases the ability of the body’s immune system to help detect and fight tumour cells.
A breakthrough therapy designation is given by the US Food and Drug Administration (FDA) to accelerate the development and regulatory review of potential new medicines for serious conditions that address a significant unmet medical need.
